Catheters may be inserted into a patient's vasculature and deployed at various locations within the patient for a wide variety of purposes and medical procedures. For example, one type of catheter is used in percutaneous catheter intervention (PCI) for the treatment of a vascular constriction generally known as a stenosis. In this instance, the catheter has a distally mounted balloon that can be placed, in a deflated or unexpanded condition, within the stenosis, and then inflated or expanded to dilate the narrowed lumen of a blood vessel. This type of balloon dilation therapy is generally referred to as percutaneous transluminal angioplasty (PTA). When the treatment is more specifically intended for vessels of the heart, the process is known as percutaneous transluminal coronary angioplasty (PTCA). In other PCI procedures a stent is expanded into contact with the vessel wall to prevent narrowing or restenosis of the artery.
For example, FIGS. 1 and 2 illustrate the deployment of a PTCA treatment catheter 16 within a patient's vasculature. To treat small diameter vessels remote from an entry point into a patient, a guiding catheter 10 may be used to span the distance. Guiding catheter 10 is typically inserted into a large artery 112 near the patient's groin and is then advanced towards the heart H to the entry opening or ostium of a diseased coronary artery. Guiding catheter 10 provides a conduit through which catheters and guidewires, such as treatment catheter 16 and a guidewire 18, can be passed from outside the patient to the vessel being treated. Treatment catheter 16 generally includes a flexible elongated tubular shaft and a luer fitting 14. For certain interventional procedures, treatment catheter 16 may include a dilatation balloon and/or a stent disposed along a distal portion thereof.
Referring now to FIGS. 3-4, catheters are commonly packaged and stored in a packaging hoop 11 as shown in FIG. 3 in accordance with the teachings of the prior art. Packaging hoop 11 consists of a coiled tube 13 having a proximal opening 17 through which treatment catheter 16 is inserted. Several clips 15 are coupled to tube 13 to maintain the tube in the coiled configuration. The overall diameter of packaging hoop 11 is selected to be as small as possible without imparting a lasting curve shape to the generally straight medical device during the shelf life thereof. An overly small diameter hoop 11 may also require excessive friction forces and thereby possibly cause product damage during loading or unloading of the medical device. Luer fitting 14, located at the proximal end of treatment catheter 16, has an area 19 that fits into proximal opening 17 of tube 13, as shown in FIG. 4, in order to secure treatment catheter 16 in packaging hoop 11 until it is removed for clinical use. One potential issue with utilizing clips 15 for holding tube 13 in the coiled configuration is that the packaging may not stay flat because clips 15 cannot grip tube 13 with much force without undesirably pinching or kinking the tubing and thereby restricting the loading and unloading of treatment catheter 16. Furthermore, tube 13 may separate from clips 15 during distribution. In addition, coiled tube 13 is typically formed from an extrusion having a circular cross-section since extruded tubing having a non-circular profile will be predisposed to bend around the profile's major axis. Although non-circular cross-section tubing can be forced to bend around its minor axis to thereby create a hoop 11 having certain advantages such as reduced height, clips 15 cannot constrain coiled tube 13 in this unnatural configuration. Certain catheter device configurations may require the extruded tubing to have an increased diameter and attendant greater stiffness, which may require additional clips 15 to hold tube 13 in the coiled configuration and still has a greater tendency to fall out of plane and not stay flat.
In addition to coiled tube 13 and clips 15, catheter packaging typically includes or requires additional parts or components including a disposable loading tube (not shown) that is necessary to initially load treatment catheter 16 and a finishing tube (not shown) that protects the distal end of catheter 16 during distribution. Various other accessories or components (not shown) may be included in packaging for a catheter, including but not limited to a cannula, a cannula holder, a “looper” or fastener used to clip the catheter in a loop after it is taken out of tube 13, a desiccant and oxygen scavenger, and/or instructions for use that may be associated with the packaging and/or catheter 16. All of the separate components must be assembled together in a cohesive package that is easy to handle and use by operating room personnel.
Accordingly, there remains a need in the art for improved packaging that overcomes these and other disadvantages of currently available catheter packaging.